Director, Regulatory Affairs - In-Vitro Diagnostics (IVD)
Amgen(1 month ago)
About this role
The Director of Regulatory Affairs - In-Vitro Diagnostics (IVD) at Amgen leads the regulatory function for diagnostic and companion diagnostic products, shaping global regulatory strategy to support product development and approvals. Based in Thousand Oaks, CA, the role partners across internal teams and external stakeholders to align regulatory planning with business and product timelines.
Required Skills
- Regulatory Strategy
- Team Leadership
- Resource Allocation
- SOP Development
- Cross-Functional Leadership
- IVD/CDx
- Submission Planning
- Global Regulations
- Post-Market Compliance
- Stakeholder Management
+7 more
Qualifications
- Doctorate Degree
- Master's Degree
- Bachelor's Degree
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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